YY/T 1471-2016Requirements and tests for indomethacin rubber used for Cu-IUD (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the material containing indomethacin silicone rubber (hereinafter referred to as indomethacin silicone rubber) containing copper IUD, requiring that the test Methods and storage.

This standard applies to the use of copper containing IUDs containing indomethacin silicone rubber.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

Rubber, vulcanized or thermoplastic elastomers - Determination of tensile stress - strain properties GB/T

GB/T 529-2008 Determination of tear strength of vulcanized rubber or thermoplastic rubber (pants, right angle and crescent specimens)

GB/T 531.1-2008 Vulcanized rubber or thermoplastic rubber - Test method for hardness - Part 1. Shore 's hardness method (Shao Hardness)

General requirements for silicone rubber surgical implants YY 0334-2002 Pharmacopoeia of the People's Republic of China (2015)

3 Material

3.1 indomethacin silicone rubber from the indomethacin raw materials loaded in the silicone rubber mixing, curing from.

3.2 Indomethacin API [Chemical name. 2-methyl-1- (4-chlorobenzoyl) -5-methoxy-1H-indole-3-acetic acid] should meet the "Chinese The Republic of China Pharmacopoeia (two) "(2015 edition) requirements.

3.3 silicone rubber should meet the requirements of YY 0334-2002.

Note: The biological evaluation of indomethacin silicone rubber is carried out in conjunction with the biological evaluation of the final product of copper-containing IUD.

4 Requirements